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COMPLETED
NCT04221750
PHASE3

Diet and Exercise Plus Metformin to Treat Frailty in Obese Seniors

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

Summary

The continuing increase in prevalence of obesity in older adults including many older Veterans has become a major health concern. The clinical trial will test the central hypothesis that a multicomponent intervention consisting of lifestyle therapy (diet-induced weight loss and exercise training) plus metformin will be the most effective strategy for reversing sarcopenic obesity and frailty in older Veterans with obesity.

Official title: Lifestyle Intervention Plus Metformin to Treat Frailty in Older Veterans With Obesity

Key Details

Gender

All

Age Range

65 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2021-05-14

Completion Date

2025-07-31

Last Updated

2026-09-14

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Lifestyle therapy

Weight management program, in which participants are prescribed a balanced diet that provides and energy deficit of 500 to 750 kcal per day to induced \~10% weight loss plus Supervised combined aerobic and resistance exercise training three times weekly

DRUG

Metformin Hydrochloride

Given orally starting at 500 mg (one tablet) taken orally once a day with meals. After a week, the dose of metformin will be increased to 1000 mg (two tablets) daily. After another week, the dose of metformin will be increased to 1500 mg (three tablets) daily.

DRUG

Placebo

Given orally starting at 500 mg (one tablet) taken orally once a day with meals. After a week, the dose of placebo will be increased to 1000 mg (two tablets) daily. After another week, the dose of placebo will be increased to 1500 mg (three tablets) daily.

BEHAVIORAL

Healthy Lifestyle

Group educational sessions that focus on healthy diet, exercise, and social support once a month

Locations (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States